Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN PURE FORM BY USING UV SPECTROPHOTOMETRY

P. T. Nagaraju* and B. Venkata Ramana

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Abstract

A simple, specific, accurate, and precise spectroscopy method was developed and validated for the estimation of dapagliflozin in pure form. The Standard solution was prepared by weighing 100 mg of dapagliflozin in 100 ml volumetric flask with 0.1N Nitric Acid. The final Standard solution was made to produce 1000 μg / ml with 0.1N Nitric Acid. Further dilutions were prepared as per procedure and were scanned at 232 nm. The linearity was found in the concentration range of 10-60 μg / ml. The Correlation coefficient was 0.996. The regression equation was found to be Y = 0.043 X = 0.336. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The limit of detection and limit of quantitation for estimation of dapaliflozin was found to be 5.36 (μg / ml) and 17.08 (μg / ml), respectively. The percentage recovery of dapaliflozin was found to be in the range of 98.49 ± 0.0001 to 101.3 ± 0.003. Proposed method can be successfully applied for the quantitative determination of dapagliflozin in pharmaceutical pure form.

Keywords: Dapagliflozin, 0.1N Nitric Acid, UV/VISIBLE spectroscopy.